Medical tubing detection and management

ABSTRACT

A medical tubing set can comprise a fluid conduit adapted to convey a medical fluid; an optical element coupled to the fluid conduit and configured to provide illumination; and a power source configured to power the optical element. A method of operating a medical tubing set, the medical tubing set comprising a fluid conduit adapted to convey a medical fluid, an optical element coupled to the fluid conduit and configured to provide illumination, and a power source configured to power the optical element, can comprise installing the medical tubing set in a medical device at a first end and in a patient at a second end; providing a source of power with the power source; applying the source of power to the optical element; and illuminating the fluid conduit with the optical element.

RELATED APPLICATION

This application is a divisional of U.S. application Ser. No. 13/495,780filed Jun. 13, 2012, which in turn is a continuation-in-part of U.S.application Ser. No. 13/296,883 filed Nov. 15, 2011, both of which arehereby fully incorporated herein by reference.

TECHNICAL FIELD

This disclosure relates generally to medical devices. More particularly,this disclosure relates to systems for, and methods of, medical tubingdetection and management.

BACKGROUND

In critical care environments, a single patient can be connected tomultiple infusion pumps or other tubing-based delivery or removalsystems at the same time. Because of this, a multitude of medical tubingcan be near and around the patient, making it difficult for medicalprofessionals to know which tubing relates to which infusion pump,delivery system, or removal system. Further, parameters such as route ofinfusion, drug interaction, and whether the line is putting fluid intothe patient's body or carrying fluid away from the patient's body, forexample, are critical to the care of a patient. If the wrong medicationis placed in the wrong set of tubing, the results can be fatal. Thus,the organization and identification of tubing lines is vitallyimportant.

Currently, the identification of tubing lines is done by hand, often bya medical professional hand-tracing the tubing from a delivery orremoval device, through the span of tubing, and to the patient, orvice-versa. With respect to infusion systems, the medical industry hasdevised standardized colors and patterns to indicate characteristics ofmedical tubing, like route of infusion and type of tube. Thus, moreupdated methods of identifying tubing involve hand-labeling a tubingline with these standardized markings by adhering a label to the lineafter initial implementation or the tracing described above. In someinstances, a single line of tubing can have multiple labels affixed toit. However, the human-executed practices described above are not onlytime-consuming, but also prone to mistakes in labeling or identificationdue to human error and a lack of robustness in or reliability ofadhesive labels and other rudimentary visual identification schemes.

Additionally, even when the multitude of lines is labeled correctly,there remains a difficulty in reading and evaluating the labels when theroom in which the patient resides is not well lighted. For example, whena medical professional enters a patient's darkened room, such as whenthe patient is sleeping at night, in order to check the connectivity orstatus of one or more of the lines, the professional will often have toturn the overhead room lights on, or have a supplementary light toposition on the lines and labels, like a flashlight. The turning on ofroom lights or use of a flashlight around the patient may be disruptiveto the patient's sleep. Additionally, the use of a flashlight can becumbersome, especially when both of the professional's hands are neededfor patient care. Further, some drugs are sensitive to the wavelength ofcertain light, thereby limiting the types of lights that may be usedaround medical lines.

In addition, existing medical tubing provides no indication of theoperating status or, in cases of problems with the tubing or infusion,alerts for the attending medical professional. In order to check theoperating status of the infusion device and attached tubing, the medicalprofessional must first inspect the device, inspect the interface to thetubing, and subsequently trace along the tubing to evaluate a properflow. Similarly, medical professionals are often not alerted when thereis a problem with the tubing or infusion; the entire length of tubingmust be visually inspected for blockages or occlusions. Thus, inaddition to the problem of identifying existing medical tubing, aproblem exists in identifying operating and problem statuses.

Further, medical tubing detection and management has heretofore beenproblematic for medical practitioners. In hospitals, for example, theremay be a large number of tubes, cords, and cables present in patientcare areas—particularly in those areas or rooms where patients arereceiving intensive care. A relatively easy and efficient way ofidentifying and organizing medical and infusion tubing is thereforedesirable, along with identification of corresponding tubing sets anddrug infusion routes. Such information could be vitally important in,e.g., determining acceptable compatibilities and desired interactions ofdrugs being administered to a patient.

Therefore, there is a need for an automated, safe, and effective way ofidentifying medical tubing, as well as for identifying any operatingstatuses or problem statuses with the flow of the medical liquid withinthe tubing. There is also therefore a need for systems for, and methodsof, medical tubing detection and management.

SUMMARY

Embodiments relate to illuminated medical tubing, such that individualmedical lines are identifiable based on an illumination or color scheme.This disclosure also describes novel and inventive systems for, andmethods of, medical tubing detection and management.

In an embodiment, a medical tubing set comprises a fluid conduit adaptedto convey a medical fluid; an optical element coupled to the fluidconduit and configured to provide illumination; and a power sourceconfigured to power the optical element.

In an embodiment, a method of operating a medical tubing set, themedical tubing set comprising a fluid conduit adapted to convey amedical fluid, an optical element coupled to the fluid conduit andconfigured to provide illumination, and a power source configured topower the optical element, the method comprises installing the medicaltubing set in a medical device at a first end and in a patient at asecond end; providing a source of power with the power source; applyingthe source of power to the optical element; and illuminating the fluidconduit with the optical element.

The subject matter hereof thereby improves the way medical tubing isidentified in a critical care environment. Because the tubing provides avisual indication, no hand-tracing of tubing from, e.g., the infusiondevice, through the span of tubing, and into the patient is required.Additionally, labels adhered to the tubing, or other rudimentary visualidentification schemes, are no longer needed to identify characteristicsof the tube, like route of infusion and type of tube; thesecharacteristics can be indicated by the illumination component.Likewise, because the tubing is illuminated, the tubing is identifiableeven in a darkened room, and thus no supplementary light is needed toidentify individual tubes or labels. Further, sensors integrated intothe tubing, like pressure sensors, occlusion sensors, fluid flowsensors, temperature sensors, liquid density sensors, air bubblesensors, salinity sensors, pH sensors, dissolved oxygen sensors,conductivity sensors, and electrolyte sensors, for example, provide dataabout the tubing and fluid that can be accumulated and subsequentlyreported as a visual indication by the illumination component. In thisway, emergency situations can be instantaneously expressed by a visualindication. Manufacturing advantages also exist in embodiments. Existingmedical tubing manufacturing can be modestly altered or supplemented inorder to produce the tubing of the subject matter hereof. Similarly, inembodiments, existing medical devices and medical tubing can be retrofitsuch that the subject matter hereof is usable on devices and tubing notoriginally designed for it. In another advantage, various components ofembodiments are highly reusable, thus lowering the cost topractitioners.

The most common source of occlusions is a clamp on the medical tubingthat is previously applied to the tubing but subsequently forgotten byhospital staff. Consequently, in another advantage, when a clamp isplaced on embodiments, the clamp also acts as a stimulus for the passingillumination by blocking, altering, restricting, or otherwise changingthe optical path. As a result, in embodiments, the passing illuminationis mostly terminated, and thereby highlighted, at the forgotten clamp.Embodiments can thus provide a readily discernable visual indication offorgotten clamps.

The above summary of the subject matter hereof is not intended todescribe each illustrated embodiment or every implementation thereof.The figures and the detailed description that follow more particularlyexemplify these embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

The subject matter hereof may be more completely understood inconsideration of the following detailed description of variousembodiments in connection with the accompanying drawings, in which:

FIG. 1A depicts a block diagram of a tubing set system according to anembodiment.

FIG. 1B depicts a block diagram of a tubing set system according to anembodiment.

FIG. 1C depicts a block diagram of a tubing set system according to anembodiment.

FIG. 2 depicts a block diagram of a tubing set system according to anembodiment.

FIG. 3 is a perspective view of a dual lumen tubing set according to anembodiment.

FIG. 4 is a perspective view of a tubing set utilizing an inner lumenand an outer lumen according to an embodiment.

FIG. 5 is a perspective view of a tubing set utilizing anelectroluminescent (EL) wire according to an embodiment.

FIG. 6 is a perspective view of a tubing set utilizing an EL wireaccording to an embodiment.

FIG. 7 is a perspective view of a tubing set utilizing an interioroptical coating according to an embodiment.

FIG. 8A is a perspective view of a tubing set utilizing an exterioroptical coating according to an embodiment.

FIG. 8B is a perspective view of a tubing set utilizing both an interioroptical coating and an exterior optical coating according to anembodiment.

FIG. 9 is a perspective view of a tubing set utilizing light-emittingdiodes (LEDs) according to an embodiment.

FIG. 10 is a flowchart of the operation of a tubing set according to anembodiment.

FIG. 11 is an illustration of an embodiment of a system for medicaltubing detection and management.

FIG. 12 is an illustration of another embodiment of a system for medicaltubing detection and management.

While the subject matter hereof is amenable to various modifications andalternative forms, specifics thereof have been shown by way of examplein the drawings and will be described in detail. It should beunderstood, however, that the intention is not to limit the subjectmatter hereof to the particular embodiments described but rather tocover all modifications, equivalents, and alternatives falling withinthe spirit and scope of the subject matter hereof as defined by theappended claims.

DETAILED DESCRIPTION

Embodiments relate to an illuminated medical tubing set that providesvisual indications of characteristics relating to the type and operatingstatus of the tubing. In embodiments, single and dual lumen tubing canbe used. In one dual lumen embodiment, one lumen is used is used as thelighted channel, and the other lumen is used to transport the drug orfluid. In another embodiment, an inner lumen is nested within an outerlumen, whereby either the inner lumen is used as the lighted channel andthe outer lumen is used as the fluid conduit, or the outer lumen is usedas the lighted channel and the inner lumen is used as the fluid conduit.The inside surface of a single channel of tubing is optically coatedwith a side-emitting material in another embodiment. In such anembodiment, a single channel is utilized as the conduit for both thetransportation of the fluid and the transportation of the light orcolor. In another embodiment, the outside surface of a single channel oftubing is optically coated with a side-emitting material. Both theoutside and inside surfaces of a single channel of tubing are opticallycoated with a side-emitting material in another embodiment. In yetanother embodiment, a segment of electro-luminescent (EL) wire iscoupled to medical tubing such that, when current is passed through theEL wire, the wire and consequently, the adjoining tubing, areilluminated. Light-emitting diodes (LEDs) are positioned at oppositeends of or along the tubing in order to illuminate the length of tubingin another embodiment. Various other combinations and configurations ofthese and other components can be implemented in other embodiments.

Embodiments also relate to systems for, and methods of, medical tubingdetection and management, that may provide relatively easy and efficientways of identifying and organizing medical and infusion tubing,identifying corresponding tubing sets and drug infusion routes, anddetermining acceptable compatibilities and desired interactions of drugsbeing administered to a patient.

Referring generally to FIGS. 1A-1C, block diagrams of an illuminatedtubing set system 100 are depicted, according to embodiments.Embodiments of illuminated tubing set system 100 generally comprise anoptical element 102, a fluid conduit 104, and a power source 110.Example embodiments of illuminated tubing set 100 are described below.In general, power source 110 interfaces with optical element 102, andoptical element 102 is configured to illuminate tubing set 100.Optionally, and as depicted in FIG. 2, in another embodiment,illuminated tubing set 150 can further comprise a pressure sensor 106and a microcontroller 108. Additional sensors, such as to monitor othercharacteristics of the tubing, fluid, or surrounding environment, canalso be included in other embodiments. For example, an occlusion sensor,temperature sensor, flow sensor, liquid density sensor, air bubblesensor, salinity sensor, pH sensor, dissolved oxygen sensor,conductivity sensor, electrolyte sensor, or any combination thereof, canbe included in embodiments.

In another embodiment (not depicted), illuminated tubing set 150 cancomprise optical element 102, fluid conduit 104, power source 110, andone or more sensors, without microcontroller 108. Further, one or moresensors can comprise, for example, a pressure sensor, occlusion sensor,temperature sensor, flow sensor, liquid density sensor, air bubblesensor, salinity sensor, pH sensor, dissolved oxygen sensor,conductivity sensor, electrolyte sensor, or any combination thereof. Inembodiments without microcontroller 108, an integrated circuit (IC) orother generic chip can optionally be included. The IC is configured toprovide information to device interface 112 via an electronic signal. Inan embodiment, the IC can provide identifying information such as partnumber, lot number, or expiration date, for example.

Referring again to FIG. 1A, optical element 102 provides an illuminatedvisual indicator for tubing set 100. In embodiments, optical element 102runs continuously and lengthwise for the length of tubing set 100, asdepicted, for example, in FIG. 1C. The visual indicator in embodimentscould therefore be substantially as bright and illuminated at themidpoint of tubing set 100 as it is at the interface to power source110. For example, in an embodiment, optical element 102 comprises aside-emitting optical coating running the length of tubing set 100 and alight-generating element, such as a laser or other concentrated lightsource. In such an embodiment, power source 110 powers thelight-generating element, which directs light along the side-emittingoptical coating. Light is reflected along the length of tubing set 100to illuminate tubing set 100. The optical coating can comprise anadhesive acrylate-based cladding solution, or any other coatingappropriate for a plastic or silicone substrate. In an embodiment, theoptical path for optical element 102 is co-extruded with fluid conduit104 at the time of manufacture. In another embodiment, optical element102 comprises an illuminated EL wire running the length of tubing set100. In another embodiment, optical element 102 is positioned atdiscrete points along tubing set 100, for example, and comprises one ormore illuminable LEDs, such as multi-color LEDs. In such an embodiment,power source 110 powers discrete lights or indicator elements at certainillumination points, for example, at the interface point with powersource 110, as depicted, for example, in FIG. 1B. Both a greater numberand lesser number of illumination points are considered. For example,optical element 102 points can be at the interface with power source 110and near the patient contact site. In another example, illuminationpoints can be at the interface point with power source 110, at themidpoint of tubing set 100, and near the infusion or patient contactsite.

Optical element 102 can be configured to provide white light or coloredlight, or to provide no light, or to selectively alternate between oneor more lighted and/or non-lighted settings. Further, optical element102 can provide varying degrees of brightness. In certain situations,like when a patient's room is darkened—at night, for example—thebrightness of optical element 102 can be reduced. The reduced intensitylight of optical element 102 is still easily visible in the darkenedambient lighting, yet not bright enough to disturb the patient.Conversely, when the ambient lighting is brightened—during the day, forexample—the brightness of optical element 102 can be increased toincrease the ease of visibility of tubing set 100. Additionally, opticalelement 102 can be configured to provide flashing or patterned light.Examples of such flashing or patterned light are given below. Additionaloptical elements, like a chemiluminescent fluid, can also be included inother embodiments.

Fluid conduit 104 is used to transmit fluid in a critical careenvironment. For example, fluid conduit 104 can transmit medication froman infusion pump 101 to a patient. Alternatively, fluid conduit 104 canprovide the conveyance for removing fluid from a patient. Fluid conduit104 generally comprises a cylinder with a diameter wide enough for fluidto flow appropriately for the medical application. Thus, fluid conduit104 can have diameters of different sizes in various embodiments. Forexample, fluid conduit 104 having diameters of about 0.015 inches toabout 3.0 inches are contemplated. Other diameters are also considered.Fluid conduit 104 is typically made of a flexible silicon plasticappropriate for a medical environment, such that it is odorless,tasteless, and inert. Further, fluid conduit 104 is nonreactive to bodytissues and fluids and can withstand repeated sterilizations. Otherappropriate materials are also considered, like polyvinyl chloride orany other appropriate thermoplastic polymer. Fluid conduit 104 can alsobe of varying lengths, depending on the medical application. Inembodiments, fluid conduit 104 can provide the conveyance for both themedical fluid as well as the housing for optical element 102. Typically,fluid conduit 104 is clear or transparent so that the fluid flowingthroughout fluid conduit 104 is visible through the walls of thecylinder. In other embodiments, however, fluid conduit 104 can bepartially or fully translucent or opaque.

Power source 110 provides a source of the power for optical element 102.In embodiments, power source 110 can be integrated into the medicaldevice to which tubing set 100 interfaces. In other embodiments, powersource 110 can be integrated within the body of fluid conduit 104 oranother portion of tubing set 100 itself. Power source 110 generates orconveys the power required of the particular embodiment of opticalelement 102. For example, power source 110 can be a battery. In anotherexample, power source 110 is an electrical connection to the powersource of the medical device.

In an embodiment, for example one in which optical element 102 comprisesa light-generating element and a side-emitting optical coating fromwhich light can reflect, power source 110 is a battery that powers thelight-generating element. A beam of focused light is directed by thelight-generating element appropriately along the sides of the conduit ofthe optical coating to illuminate tubing set 100. In another embodiment,power source 110 comprises a source of alternating current, whereoptical element 102 comprises, for example, a length of EL wire. Thealternating current is applied to the EL wire to illuminate the wire,the conduit housing optical element 102 and thus, tubing set 100. Inanother embodiment, power source 110 includes a voltage source designedto power an LED, where optical element 102 comprises an LED. Theabove-described power sources are provided for example only and are notintended to be limiting for power source 110. Any appropriate powersource can be used. For example, in embodiments, direct current,battery, photovoltaic, linear regulated, switched mode power sources, orany other useful power source can be utilized.

In embodiments, and referring to FIG. 2, tubing set 150 can furthercomprise pressure sensor 106. Pressure sensor 106 is used to monitor thepressure of the fluid within fluid conduit 104. By measuring thepressure, emergency or alertable situations can be detected for thefluid flow within fluid conduit 104. In embodiments (not depicted), atubing set can comprise any useful sensor, for example, occlusionsensor, temperature sensor, flow sensor, liquid density sensor, airbubble sensor, salinity sensor, pH sensor, dissolved oxygen sensor,conductivity sensor, electrolyte sensor, or any combination thereof.Similar to the above-described monitoring of pressure sensor 106, any ofthe aforementioned sensors can monitor fluid conduit 104 andsubsequently relay emergency or alertable situations, depending on thespecifics of the respective sensor.

In embodiments, tubing set 150 can further comprise microcontroller 108.Microcontroller 108 is used to capture the pressure sensed by pressuresensor 106. Algorithms regarding pressure changes can be programmed intomicrocontroller 108. In an example, if the measured pressure is outsideof a particular boundary or the measured delta is outside limits placedon a previously-measured acceptable value, an alert situation may bepresent. Further, microcontroller 108 provides an interface to controlpower source 110. In this way, various colored lights or flashingpatterns can be implemented. In the alert situation described above,microcontroller 108 can signal to power source 110 that a non-standardoperating status should be indicated. Myriad algorithms can beimplemented, given this framework, to alert and provide status of theoperation of the tubing set. Examples are given herein below.

Device interface 112 can provide an interface for programming basicoperation, alarm indicators (including appropriate limits), colors, andother operating parameters into microcontroller 108. In an embodiment,device interface 112 is implemented as part of a medical device, such asan infusion pump 101. In another embodiment, device interface 112 isimplemented as a stand-alone component of tubing set 150.

Device interface 112 can be configured to provide standardized operatingparameters to microcontroller 108. Standardized profiles orconfigurations having standardized operation, alarm indications, colors,and other operating parameters can be implemented for each medicaldevice for a particular hospital site. Each type of medical device canhave a specific profile with operating parameters unique to that device.Similarly, a specific profile can be developed for each set of tubingimplemented having a specific sensor or set of sensors. Device interface112 can be configured to install these profiles, and thereby adjust theoperating settings, prior to the use of the medical device. For example,a particular hospital could standardize all occlusion pressure alarms toflash tubing set 150 with the color red. Such a configuration allows foruniformity across an entire hospital site, thus further easing burden onmedical professionals and further providing value with tubing set 150use. At that particular hospital site, all medical professionals wouldknow that a flashing red tubing set indicates an occlusion problem.

Referring to FIG. 3, an embodiment of a dual lumen tubing set 300 isdepicted. Dual lumen tubing set 300 generally comprises an opticalinterface 302 and a fluid conduit 304. Optical interface 302 can be, forexample as described above with respect to optical interface 102, afiber optic channel, a length of EL wire extending throughout thechannel, or a series of LEDs placed along the channel, among others.Optical interface 302 and fluid conduit 304 are immediately adjacenteach other in one embodiment so that when optical interface 302 isilluminated, fluid conduit 304 is also illuminated.

Referring to FIG. 4, an embodiment of a dual lumen tubing set 400 isdepicted. Dual lumen tubing set 400 generally comprises an inner lumen402 and an outer lumen 404. Inner lumen 402 is nested within outer lumen404 such that inner lumen 402 is completely enclosed by outer lumen 404.In an embodiment, inner lumen 402 provides the fluid conduit and outerlumen 404 provides the housing for the optical interface for dual lumentubing set 400. When illuminated using appropriately clear ortransparent lumens, the optical element in outer lumen 404 illuminatesinner lumen 402 and the fluid flowing throughout. In another embodiment,inner lumen 402 provides the housing for the optical interface and outerlumen 404 provides the fluid conduit for dual lumen tubing set 400. Whenilluminated, the optical element in inner lumen 402 illuminates outerlumen 404 and the fluid flowing throughout. In embodiments, the opticalinterface can be, as described above with respect to optical interface102, a fiber optic channel, a length of EL wire extending throughout thechannel, or a series of LEDs placed along the channel. In other nestedembodiments (not depicted), additional lumens can extend throughout theoutermost lumen, with multiple fluids flowing throughout, depending onthe medical application. Whichever lumen is chosen as the fluid conduitcan illuminate the remaining fluid conduit lumens.

Referring to FIG. 5, an embodiment of tubing set 500 using an EL wire isdepicted. Tubing set 500 generally comprises an optical element 502 anda fluid conduit 504. In such an embodiment, optical element 502 is alength of EL wire. Optical element 502 is encircled around and coupledto the outer wall of fluid conduit 504 in a crisscrossing pattern.Similarly, referring to FIG. 6, another embodiment of a tubing set 600using EL wire is depicted. Tubing set 600 generally comprises an opticalelement 602 and a fluid conduit 604. Again, in such an embodiment,optical element 602 is a length of EL wire. Optical element 602 iscoupled to the outer wall of fluid conduit 604 along one side of theouter wall. When optical element 502 or optical element 602 areilluminated, respective fluid conduits 504 or 604 are similarlyilluminated. In operation, to illuminate optical element 502 or 602 andthus fluid conduit 504 or 604, an alternating current is applied to oneend of the EL wire of optical element 502 or 602.

Referring to FIG. 7, an embodiment of tubing set 700 comprising aside-emitting optical coating is depicted. Tubing set 700 generallycomprises an optical element 702 and a fluid conduit 704. In such anembodiment, optical element 702 comprises a side-emitting opticalcoating and a light-generating element. The side-emitting coating ofoptical element 702 is coated along the inside walls of fluid conduit704. The combination of the light-generating element and the opticalcoating, when light is directed by the light-generating element alongthe coated walls of fluid conduit 704 provides an illuminated fluidconduit 704. Tubing set 700 therefore has a single conduit; fluidconduit 704 provides the conveyance for both the medical fluid as wellas the housing for the optical element.

Similarly, referring to FIG. 8A, an embodiment of tubing set 800 alsocomprising an optical coating is depicted. Tubing set 800 generallycomprises an optical element 802 and a fluid conduit 804. Similar totubing set 700, optical element 802 comprises a side-emitting opticalcoating and a light-generating element. However, unlike tubing set 700,tubing set 800 has the optical coating along the outer wall of fluidconduit 804.

In operation, to illuminate fluid conduit 704 or 804, a beam of focusedlight is directed appropriately at one end of fluid conduit 704 or 804by the light-generating element of optical element 702 or 802,respectively, so that the light reflects along the coated sides of fluidconduit 704 or 804, respectively.

Referring to FIG. 8B, an embodiment of tubing set 850 also comprising anoptical coating is depicted. Tubing set 850 is a combination of tubingset 700 and tubing set 800. Tubing set 850 generally comprises an insideoptical element 702 and an outside optical element 802, both opticalelements 702 and 802 comprising a coating of side-emitting material suchthat there is optical coating on both the interior and exterior of thetubing wall, and a fluid conduit 854. In tubing set 850, the tube wallitself comprises the optical path.

In operation, to illuminate fluid conduit 854, a beam of focused lightis directed appropriately within the wall of fluid conduit 854 by thelight-generating element of optical element 702 or 802, respectively, sothat the light reflects within the coated sides of fluid conduit 854.The combination of the light-generating element and the two opticalcoatings, when light is directed by the light-generating element withinthe wall of fluid conduit 854 provides an illuminated fluid conduit 854.

Referring to FIG. 9, an embodiment of tubing set 900 having one or moreLEDs is depicted. Tubing set 900 generally comprises an optical element902 and a fluid conduit 904. In such an embodiment, optical element 902comprises at least one LED. As depicted, optical element 902 ispositioned near an opening of fluid conduit 904, though otherpositionings, configurations, and arrangements are possible in otherembodiments. As appropriate, additional optical elements 902 can bepositioned along fluid conduit 904 to provide consistent illumination offluid conduit 904 when optical elements 902 are illuminated. Inoperation, to illuminate optical element 902, a voltage is applied tothe LED to thereby illuminate the LED and fluid conduit 904.

In operation generally, referring to FIG. 10, a tubing set is installedat 1002. Depending on the embodiment and application, installation canbe any variation of securely coupling one end of the tubing set to amedical device, such as infusion pump 101, and the opposite end to apatient, or as a drain from a patient to a waste-capturing device. Fluidconduit 104 is appropriately coupled to the fluid source. Further,optical element 102 and power source 110 are appropriately coupledtogether if required. For example, one installation can be connecting aninfusion pump 101 to a patient at an infusion site. Infusion pump 101can have an integrated power source 110 that is operably couplable tothe optical element 102 of the tubing itself. Another installation canbe connecting a feeding device to a patient at a feeding site where thetubing itself contains the power source 110, not the feeding device.Upon correct installation, the tubing set can illuminate or flash aknown pattern or sequence to indicate correct installation.

At 1004, operating parameters are set. The color of tube, illuminationintensity, and alarm limits for the various coupled sensors, and otheroperating parameters are programmed into microcontroller 108 via deviceinterface 112. In some embodiments, the operating parameters are setautomatically upon installation of the tubing set. For example, becauseof the standardization of colors and patterns in the medical industry,any tubing set connected to a specific device requiring a standard coloror pattern can automatically be programmed by the device via deviceinterface 112 to set microcontroller 108 with the standardizedillumination, standard limits, and standard intensity for theapplication, without any additional human intervention. If the medicalprofessional desires a different color scheme limits, or intensity,device interface 112, which can reside on a medical device, or as aseparate interface, can be utilized to program microcontroller 108.

At 1006, an initial set of tubing characteristics are sensed. Ifpressure sensor 106 is present in the tubing set embodiment, as depictedin FIG. 2, the pressure of the tube is sensed. Further, oralternatively, any additional sensors, as described above, are activatedto capture their respective sensor indications. At 1008, a check ofoperating limits is conducted. The decision point at 1008 is utilized toensure that operation of the tube is within the set limits. This type oflimit or boundary check is conducted for all attached sensors, or if,desired, fewer than all attached sensors. If, for example, the pressuresensed by pressure sensor 106 is inside of expected limits, normaloperation results at 1010. Normal operation 1010 can include a solidillumination at the desired programmed light intensity, or noillumination, if desired. If, however, the pressure sensed by pressuresensor 106 is outside of expected limits, alert operation results at1012. Alert operation 1012 can include a flashing or patternedillumination to indicate some sort of problem with the tubing set. Forexample, a quicker flash might indicate a pressure or occlusion problem,whereas a slower flash might indicate a temperature problem. In anotherexample, a pattern of three quick flashes followed by a pause of noillumination might indicate an improperly connected tubing set. In yetanother example, a short flash followed by a long flash might indicate amicrocontroller 108 fault. Any number of flashing or patterned flashescan be implemented to indicate status. Further, any attached medicaldevice can utilize the illumination capability of the tubing set toindicate status for the medical device by operation via device interface112.

In either the case of normal operation 1010 or alert operation 1012,power source 110 interfaces with optical element 102 to illuminateoptical element 102 and the tubing set. When the tubing set is in normaloperation, the recursive loop from normal operation at 1010 back tosense tubing characteristics at 1006 can be conducted in real time, orupon expiration of a standard or programmed wait period. Further, inoperation, any of the operating parameters can be adjusted while thetubing set is in use.

With reference now to FIG. 11, a system for medical tubing detection andmanagement 1100 could include an infusion manifold housing 1110 havingat least one fluid channel 1120 therethrough. At least one fluid inputport 1130 could be provided in infusion manifold housing 1110. Eachinput port 1130 could be configured to connect fluidically toilluminated medical tubing IT, respectively, and be in fluidiccommunication with fluid channel 1120 through infusion manifold housing1110. As used throughout this document, the term “illuminated medicaltubing” includes any suitable illuminated or otherwise opticallyidentifiable medical tubing or lines used with, e.g., infusion pumps,substance delivery systems, and substance removal systems, such as thosedescribed by example or otherwise contemplated herein. A fluid outputport 1140 could be provided in infusion manifold housing 1110, and beconfigured to be in fluidic communication with fluid channel 1120through infusion manifold housing 1110. Fluid output port 1140 couldalso be configured to connect fluidically to fluid output tubing OT. Asused throughout this document, the phrases “connect fluidically” and“fluidic communication” are intended to refer to connections, andconduits or means of transmission, that satisfactorily facilitatemovement of fluid through or between intended paths and locations. Atleast one photosensor 1150 could be provided in infusion manifoldhousing 1110. As used throughout this document, the term “photosensor”includes any suitable devices that are capable of sensing or detectinglight or other electromagnetic energy such as, e.g., optical sensors andphotodetectors. Each photosensor 1150 could be configured to receivelight from the illuminated medical tubing IT that is connected,respectively, to each fluid input port 1130 (that is, in turn,associated respectively with each photosensor 1150). Each photosensor1150 could generate an output signal (not depicted in the drawing) inresponse to light received from the illuminated medical tubing IT. Suchoutput signal could be, for example, transmitted to a computer or otherdisplay means by any suitable signal processing or transmissiontechniques (e.g., wireless transmitters and receivers) for organizinginfusion sets or drug compatibility verification as will be described.It is to be appreciated and understood that at least one infusion pump1101 could be fluidically connected to the illuminated medical tubingIT. In such an application of system 1100, each infusion pump 1101 couldbe configured to generate a light output (not depicted) that would beconducted from the illuminated medical tubing IT associated with thatpump 1101 to each respective photosensor 1150 in housing 1110. The lightoutput from each infusion pump 1101 could be indicative of at least onecharacteristic of the pump 1101, as will be described below.

Referring now to FIG. 12, a system for medical tubing detection andmanagement 1200 could include an infusion manifold housing 1210 havingat least one fluid channel 1220 therethrough. At least one fluid inputport 1230 could be provided in infusion manifold housing 1210. Eachinput port 1230 could be configured to connect fluidically toilluminated medical tubing IT, respectively, and be in fluidiccommunication with fluid channel 1220 through infusion manifold housing1210. A fluid output port 1240 could be provided in infusion manifoldhousing 1210, and be configured to be in fluidic communication withfluid channel 1220 through infusion manifold housing 1210. Fluid outputport 1240 could also be configured to connect fluidically to fluidoutput tubing OT. At least one light pipe 1260 could be provided ininfusion manifold housing 1210. As used throughout this document, theterm “light pipe” is intended to include any suitable means or devicesfor conducting or transmitting light through, or between, intended pathsand locations. Each light pipe 1260 could have a first end 1262 and asecond end 1264; and the first end 1262 could be optically connected toeach fluid input port 1230, respectively. As used throughout thisdocument, the term “optically connected” is intended to refer toconnections, and conduits or means of transmission, that satisfactorilyfacilitate transmission of light through or between intended paths andlocations. At least one lens 1270 could be included in infusion manifoldhousing 1210. Each lens 1270 could be optically connected to second end1264 of each light pipe 1260, respectively, and be configured totransmit light from each light pipe 1260, respectively, outwardly frominfusion manifold housing 1210. At least one photosensor 1250 could beprovided externally from infusion manifold housing 1210. In this regard,it is to be appreciated and understood that manifold housing 1210 andits associated, aforedescribed components could be deemed to bedisposable—or for a single use or for use with a single patient—whileeach of the potentially more expensive photosensors 1250 could be reusedsince they are remote and separate from disposable housing 1210. Thus inone embodiment, although not illustrated, photosensors 1250 could becontained within a sensor housing as part of a pump racking device or beprovided on, e.g., an intravenous apparatus or bedside utility pole.Irrespective of a particular embodiment, generally each photosensor 1250could be configured to receive light from each lens 1270 and theilluminated medical tubing IT that is connected, respectively, to eachfluid input port 1230 (that is, in turn, associated respectively witheach light pipe 1260). Each photosensor 1250 could generate an outputsignal (not depicted in the drawing) in response to light received fromthe illuminated medical tubing IT. Such output signal could be, forexample, transmitted to a computer or other display means by anysuitable signal processing or transmission techniques (e.g., wirelesstransmitters and receivers) for organizing infusion sets or drugcompatibility verification as will be described. It is to be appreciatedand understood that at least one infusion pump 1201 could be fluidicallyconnected to the illuminated medical tubing IT. In such an applicationof system 1200, each infusion pump 1201 could be configured to generatea light output (not depicted) that would be conducted from theilluminated medical tubing IT associated with that pump 1201 to eachrespective photosensor 1250 located externally from housing 1210. Thelight output from each infusion pump 1201 could be indicative of atleast one characteristic of the pump 1201, as is next described below.

Referring to both FIGS. 11 and 12, it is to be appreciated andunderstood that the output signal from each photosensor 1150 or 1250,that could be transmitted to a computer or other display means asaforementioned, could provide a relatively easy and efficient way oforganizing infusion sets and providing drug compatibility verificationto medical practitioners utilizing system 1100 or 1200. In particular,light output from infusion pumps 1101 or 1201 being received by sensors1150 or 1250 could be indicative of at least one characteristic of eachpump 1101 or 1201 such as, e.g., an identification of a drug beingdelivered to a patient or a “route of infusion” to the patient. Forexample, a particular system 1100 or 1200 could be designated as“Epidural Only”; and if a pump 1101 or 1201 for an intravenous drug waserroneously connected to that system 1100 or 1200, then an alarm signalcould be generated from each sensor 1150 or 1250 before suchincompatible or adverse drug is delivered to the patient.

An example of a method of medical tubing detection and management couldinclude a step of providing a system for medical tubing detection andmanagement such as, e.g., shown in FIG. 11. The system could include aninfusion manifold housing having at least one fluid channeltherethrough. At least one fluid input port could be in the infusionmanifold housing, and be configured to connect fluidically toilluminated medical tubing and be in fluidic communication with eachfluid channel in the infusion manifold housing. A fluid output portcould be in the infusion manifold housing and be configured to be influidic communication with each fluid channel in the infusion manifoldhousing, and to connect fluidically to fluid output tubing. At least onephotosensor could be in the infusion manifold housing. Each photosensorcould be configured to receive light from the illuminated medical tubingthat is connected to each fluid input port and generate an output signalin response thereto. This example of a method could also include a stepof fluidically connecting at least one infusion pump 1101 to theilluminated medical tubing. Each infusion pump 1101 could be configuredto generate a light output that is conducted from the illuminatedmedical tubing to each respective photosensor in the infusion manifoldhousing. The light output from each infusion pump 1101 could beindicative of at least one characteristic of each pump 1101; and eachpump characteristic could include, e.g., an identification of a drugbeing delivered to a patient from the fluid output tubing.

Another example of a method of medical tubing detection and managementcould include a step of providing a system for medical tubing detectionand management such as, e.g., shown in FIG. 12. The system could includean infusion manifold housing having at least one fluid channeltherethrough. At least one fluid input port could be in the infusionmanifold housing, and be configured to connect fluidically toilluminated medical tubing and be in fluidic communication with eachfluid channel in the infusion manifold housing. A fluid output portcould be in the infusion manifold housing and be configured to be influidic communication with each fluid channel in the infusion manifoldhousing, and to connect fluidically to fluid output tubing. At least onelight pipe, having a first end and a second end, could be in theinfusion manifold housing. A first end of each light pipe could beoptically connected to each fluid input port, respectively. At least onelens could also be in the infusion manifold housing. Each lens could beoptically connected to the second end of each light pipe, respectively,and be configured to transmit light from each light pipe, respectively,outwardly from the infusion manifold housing. At least one photosensorcould be located externally from the infusion manifold housing. Eachphotosensor could be configured to receive light from each lens,respectively, and generate an output signal in response thereto. Thisexample of a method could also include a step of fluidically connectingat least one infusion pump 1201 to the illuminated medical tubing. Eachinfusion pump 1201could be configured to generate a light output that isconducted from the illuminated medical tubing to each respectivephotosensor located externally from the infusion manifold housing, viathe respective light pipes and lenses. The light output from eachinfusion pump 1201 could be indicative of at least one characteristic ofeach pump 1201; and each pump characteristic could include, e.g., anidentification of a drug being delivered to a patient from the fluidoutput tubing.

Irrespective of a particular embodiment, it is to be appreciated andunderstood that systems for, and methods of, medical tubing detectionand management—as described by example or otherwise contemplatedherein—may be generally characterized in that the systems and methodscould be configured to identify each of a plurality of infusion pumpsthat are connected, by illuminated medical tubing, respectively, to eachfluid input port in the infusion manifold housing. It is also to beappreciated and understood that the systems and methods may thus furtherfacilitate the organization and communication of visual indications ofcharacteristics relating to the types and operating statuses of theilluminated medical tubing as described herein or as disclosed in theaforecited co-pending application Ser. No. 13/296,883.

Although not particularly illustrated in FIG. 11 or 12, it is to beappreciated and understood that aforedescribed embodiments ofilluminated medical tubing (such as, e.g., various embodiments of singleand dual lumen tubing as described herein) may be used individually orin various combinations with systems for, and methods of, medical tubingdetection and management, as described or otherwise contemplated herein.

Further, although not illustrated, it is to be appreciated andunderstood that systems for, and methods of, medical tubing detectionand management, as described or otherwise contemplated herein, couldinclude any of the usual attributes of an infusion set manifold such as,e.g., fittings, seals, luer locks, and stopcocks, etc. Also, it is to beappreciated and understood that systems for, and methods of, medicaltubing detection and management, as described or otherwise contemplatedherein, could also include any desired sensors to monitorcharacteristics of the tubing, fluid, or surrounding environment (e.g.,the aforementioned pressure sensors, occlusion sensors, fluid flowsensors, temperature sensors, liquid density sensors, air bubblesensors, salinity sensors, pH sensors, dissolved oxygen sensors,conductivity sensors, and electrolyte sensors) whether individually orin any desired combinations.

Although illustrated in FIGS. 11 and 12 as embodiments with four tubinginputs, it is to be appreciated and understood that systems for, andmethods of, medical tubing detection and management, as described orotherwise contemplated herein, could include any desired number oftubing inputs provided that such systems and methods satisfactorilyfunction as aforedescribed. Analogously, any number of systems formedical tubing detection and management could be employed in aparticular care setting, as may be desired for, e.g., maintainingreadily identifiable organization of a relatively large number ofinfusion lines that each could be distinctly and extremely important intreatment of a critically ill patient.

Additionally, it is to be appreciated and understood that tubing outputsof systems for, and methods of, medical tubing detection and management,as described or otherwise contemplated herein, could also be visuallyidentifiable by, e.g., any of the aforedescribed illumination or colorscheme techniques of illuminated medical tubing, as may be desired in aparticular care setting.

Various embodiments of systems, devices and methods have been describedherein. These embodiments are given only by way of example and are notintended to limit the scope of the subject matter hereof. It should beappreciated, moreover, that the various features of the embodiments thathave been described may be combined in various ways to produce numerousadditional embodiments. Moreover, while various materials, dimensions,shapes, configurations and locations, etc. have been described for usewith disclosed embodiments, others besides those disclosed may beutilized without exceeding the scope of the subject matter hereof.

Persons of ordinary skill in the relevant arts will recognize that thesubject matter hereof may comprise fewer features than illustrated inany individual embodiment described above. The embodiments describedherein are not meant to be an exhaustive presentation of the ways inwhich the various features of the subject matter hereof may be combined.Accordingly, the embodiments are not mutually exclusive combinations offeatures; rather, the subject matter hereof may comprise a combinationof different individual features selected from different individualembodiments, as understood by persons of ordinary skill in the art.

Any incorporation by reference of documents above is limited such thatno subject matter is incorporated that is contrary to the explicitdisclosure herein. Any incorporation by reference of documents above isfurther limited such that no claims included in the documents areincorporated by reference herein. Any incorporation by reference ofdocuments above is yet further limited such that any definitionsprovided in the documents are not incorporated by reference hereinunless expressly included herein.

For purposes of interpreting the claims for the subject matter hereof,it is expressly intended that the provisions of Section 112, sixthparagraph of 35 U.S.C. are not to be invoked unless the specific terms“means for” or “step for” are recited in a claim.

1. A medical tubing set comprising: a fluid conduit adapted to convey amedical fluid; an optical element coupled to the fluid conduit andconfigured to provide illumination; and a power source configured topower the optical element.
 2. The medical tubing set of claim 1, whereinthe optical element comprises a fiber optic coating and alight-generating element.
 3. The medical tubing set of claim 1, whereinthe optical element comprises a light-emitting diode and the powersource is a voltage to power the light-emitting diode.
 4. The medicaltubing set of claim 1, wherein the optical element comprises anelectroluminescent wire and the power source is an alternating currentto power the electroluminescent wire.
 5. The medical tubing set of claim1, wherein the optical element is located in the fluid conduit.
 6. Themedical tubing set of claim 1, wherein the medical tubing set furthercomprises dual lumen tubing and the fluid conduit and optical elementare located in discrete conduits.
 7. The medical tubing set of claim 6,wherein the dual lumen tubing further comprises a nested lumen sethaving an outer lumen and an inner lumen.
 8. The medical tubing set ofclaim 1, wherein the optical element displays colored light.
 9. Themedical tubing set of claim 1, further comprising: at least one sensorconfigured to sense at least one characteristic related to the medicaltubing system.
 10. The medical tubing set of claim 9, wherein the atleast one sensor comprises a pressure sensor, an occlusion sensor, atemperature sensor, a fluid flow sensor, a liquid density sensor, an airbubble sensor, a salinity sensor, a pH sensor, a dissolved oxygensensor, a conductivity sensor, or an electrolyte sensor.
 11. The medicaltubing set of claim 10, further comprising: an integrated circuitconfigured to transmit a signal to a device interface.
 12. The medicaltubing set of claim 9, further comprising: a microcontroller configuredto receive a signal from the at least one sensor.
 13. The medical tubingset of claim 12, further comprising an interface adapted to program themicrocontroller.
 14. The medical tubing set of claim 13, wherein theinterface adapted to program the microcontroller is configured toprogram a standardized profile.
 15. The medical tubing set of claim 12,wherein the microcontroller is further configured to manage at least oneoperating mode related to the medical tubing system.
 16. The medicaltubing set of claim 12, wherein the medical tubing set is operablycoupled to a medical device and the interface is operable via theinfusion pump.
 17. The medical tubing set of claim 16, wherein themicrocontroller is housed in the medical device.
 18. A method ofoperating a medical tubing set, the medical tubing set comprising afluid conduit adapted to convey a medical fluid, an optical elementcoupled to the fluid conduit and configured to provide illumination, anda power source configured to power the optical element, the methodcomprising: installing the medical tubing set in a medical device at afirst end and in a patient at a second end; providing a source of powerwith the power source; applying the source of power to the opticalelement; and illuminating the fluid conduit with the optical element.